Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

Condition(s) targeted: Pulmonary Disease, Chronic Obstructive

Intervention: tiotropium inhalation capsules (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

Overall contact:
Boehringer Ingelheim Study Coordinator, Email: clintriage.rdg@boehringer-ingelheim.com

A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus PRN albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

Official title: A 24 Week, Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsues Administered by HandiHaler Once-Daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Diseas Subjects Naive to Meanitenance Therapy

Study design: Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary endpoint is improvement in lung function as measured by the forced expiratory volume in 1 second (FEV1) AUC0 3h post dose response at week 24 (end of study).

Secondary outcome: FEV1 and FVC parameters Physical activity and energy expenditure as determined by the activity monitor Physician´s and patient global assessments Work productivity Use of rescue medication prn albuterol (salbutamol)

Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

All subjects must have a diagnosis of COPD according to GOLD guideline criteria:

post-bronchodilator FEV1/FVC ratio < 70% (visit 1). Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years.

Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.

Exclusion Criteria:

Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.

Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.

Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.

Boehringer Ingelheim Study Coordinator, Email: clintriage.rdg@boehringer-ingelheim.com

205.365.1059 Boehringer Ingelheim Investigational Site, Leuven, Belgium; Recruiting

205.365.1057 Boehringer Ingelheim Investigational Site, Menen, Belgium; Recruiting

205.365.1058 Boehringer Ingelheim Investigational Site, Godinne, Belgium; Recruiting

205.365.1077 Boehringer Ingelheim Investigational Site, Liberec, Czech Republic; Recruiting

205.365.1075 Boehringer Ingelheim Investigational Site, Strakonice, Czech Republic; Recruiting

205.365.1079 Boehringer Ingelheim Investigational Site, Neratovice, Czech Republic; Recruiting

205.365.1061 Boehringer Ingelheim Investigational Site, Karlovy Vary, Czech Republic; Recruiting

205.365.1062 Boehringer Ingelheim Investigational Site, Praha 10, Czech Republic; Recruiting

205.365.1063 Boehringer Ingelheim Investigational Site, Tabor, Czech Republic; Recruiting

205.365.1064 Boehringer Ingelheim Investigational Site, Cvikov, Czech Republic; Recruiting

205.365.1076 Boehringer Ingelheim Investigational Site, Usti nad Labem, Czech Republic; Recruiting

205.365.1083 Boehringer Ingelheim Investigational Site, Praha 3, Czech Republic; Recruiting

205.365.1107 Boehringer Ingelheim Investigational Site, Hradec Kralove, Czech Republic; Not yet recruiting

205.365.1050 Boehringer Ingelheim Investigational Site, Ulm, Germany; Recruiting

205.365.1052 Boehringer Ingelheim Investigational Site, R�dersdorf, Germany; Recruiting

205.365.1054 Boehringer Ingelheim Investigational Site, Gelnhausen, Germany; Recruiting

205.365.1055 Boehringer Ingelheim Investigational Site, Berlin, Germany; Recruiting

205.365.1066 Boehringer Ingelheim Investigational Site, Berlin, Germany; Recruiting

205.365.1067 Boehringer Ingelheim Investigational Site, Athens, Greece; Recruiting

205.365.1069 Boehringer Ingelheim Investigational Site, ZUTPHEN, Netherlands; Recruiting

205.365.1070 Boehringer Ingelheim Investigational Site, ENSCHEDE, Netherlands; Recruiting

205.365.1071 Boehringer Ingelheim Investigational Site, SPIJKENISSE, Netherlands; Recruiting

205.365.1072 Boehringer Ingelheim Investigational Site, ETTEN LEUR, Netherlands; Recruiting

205.365.1020 Boehringer Ingelheim Investigational Site, Coimbra, Portugal; Recruiting

205.365.1022 Boehringer Ingelheim Investigational Site, Lisboa, Portugal; Recruiting

205.365.1025 Boehringer Ingelheim Investigational Site, Amadora, Portugal; Recruiting

205.365.44002 Boehringer Ingelheim Investigational Site, Garston, United Kingdom; Recruiting

205.365.44003 Boehringer Ingelheim Investigational Site, Harrow, United Kingdom; Recruiting

205.365.44004 Boehringer Ingelheim Investigational Site, Warminster, United Kingdom; Not yet recruiting

205.365.1003 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States; Recruiting

205.365.1004 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States; Recruiting

205.365.1042 Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada; Recruiting

205.365.1023 Boehringer Ingelheim Investigational Site, Palo Alto, California, United States; Recruiting

205.365.1089 Boehringer Ingelheim Investigational Site, Austell, Georgia, United States; Not yet recruiting

205.365.1024 Boehringer Ingelheim Investigational Site, Lexington, Kentucky, United States; Recruiting

205.365.1012 Boehringer Ingelheim Investigational Site, Baltimore, Maryland, United States; Recruiting

205.365.1006 Boehringer Ingelheim Investigational Site, Rochesrter, Minnesota, United States; Recruiting

205.365.1085 Boehringer Ingelheim Investigational Site, Omaha, Nebraska, United States; Not yet recruiting

205.365.1010 Boehringer Ingelheim Investigational Site, Albuquerque, New Mexico, United States; Recruiting

205.365.1007 Boehringer Ingelheim Investigational Site, Rochester, New York, United States; Recruiting

205.365.1080 Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States; Not yet recruiting

205.365.1056 Boehringer Ingelheim Investigational Site, Kingston, Ontario, Canada; Recruiting

205.365.1033 Boehringer Ingelheim Investigational Site, Pittsburgh, Pennsylvania, United States; Recruiting

205.365.1041 Boehringer Ingelheim Investigational Site, Ste-Foy, Quebec, Canada; Recruiting

Starting date: April 2007
Last updated: October 23, 2008